Pilot Study of Perioperative Docetaxel, Oxaliplatin, and 5-Fluorouracil (FLOT) in Gastroesophageal Adenocarcinoma

Gastric Adenocarcinoma Clinical Trial

Official title: Pilot Study of Perioperative Docetaxel, Oxaliplatin, and 5-Fluorouracil (FLOT) in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

Status Completed

Clinical Trial Summary

Gastric or gastroesophageal junction adenocarcinoma is commonly treated with chemotherapy before and after surgery. The chemotherapy regimen used in our institution, called DCF (docetaxel,cisplatic, 5-fluorouracil) is active, resulting in tumor reduction and dysphagia relief. however, it is toxic, causing approximately half of patients severe inflammation of the mucosa (lining) of the mouth and gut. This results, in turn, in mouth sores, vomiting and diarrhea. Similar regimen called FLOT (5-FU, oxaliplatin,docetaxel) appears to be at least equally active, but less toxic.

Our ultimate plan is to perform a randomized comparison of DCF and FLOT. Before embarking upon this, we are conducting this pilot trial in 10 subjects with the FLOT regimen. If less than 5 patients develop severe mouth sores, vomiting or diarrhea, plans will be made to proceed with the next trial, a randomized comparison of DCF and FLOT

Clinical Trial Description

Data about occurrence of diarrhea and mouth sores will be recorded through the use of quality-of-life questionnaires ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Adenocarcinoma
• Esophageal Neoplasms
• Gastric Adenocarcinoma

• NCT number: NCT01932580
• Study type: Interventional
• Source: McGill University
• Status: Completed
• Phase: Phase 2
• Start date: August 2013
• Completion date: June 2015